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HHS/FDA RIN: 0910-AA20 Publication ID: Fall 2001 
Title: Medical Foods 
Abstract: The Food and Drug Administration is considering development of regulations for medical foods, as defined by the Orphan Drug Act Amendments of 1988 (21 U.S.C. 360ee(b)(3)) to assure, among other things, the safety and effectiveness of these products, proper labeling of the nutrient content and purported uses, including adequate and appropriate directions for use, and quality control and good manufacturing practices. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 321    21 USC 360ee    21 USC 371    21 USC 342    21 USC 343    21 USC 348    21 USC 350    21 USC 350a    21 USC 351    21 USC 352    21 USC 355   
Legal Deadline:  None
Timetable:
Action Date FR Cite
ANPRM  11/29/1996  61 FR 60661   
ANPRM Comment Period End  04/28/1997    
NPRM  To Be Determined    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
Agency Contact:
Sue A. Anderson
Department of Health and Human Services
Food and Drug Administration
(HFS-831), Center for Food Safety and Applied, Nutrition, 200 C Street SW.,
Washington, DC 20204
Phone:202 205-4240